LITHE-biomarker is a double blind, placebo-controlled parallel group study comparing the effects of two approved doses of TCZ combined with MTX or with placebo on different biomarkers of joint destruction in RA patients non-responsive to DMARDs. The current sub-study evaluated serum samples from a one-year, double blinded study that randomized 704 patients (mostly women in their 50s) to intravenous TCZ at doses of 4 mg/kg (TCZ 4) or 8 mg/kg (TCZ 8) or IV placebo, all with a stable concurrent dose of MTX (10–25 mg/week), over 4 weeks:

Patients whose swollen or tender joints had not improved by 20% from baseline by week 16 or later could receive blinded rescue therapy in a stepwise fashion between weeks 16 and 28 (escape patients).

Serum biomarkers were tested at baseline,and at weeks 4, 16, 24, and 52. Patients who had a 50% improvement in swollen and tender joints according to American College of Rheumatology criteria (ACR50) were classified as responders. Others were described as either early non-responders (tje escape patients) or as non-responders.

A year later, among the responders, TCZ8 had inhibited C-reactive protein (CRP) to 4% of baseline levels and TCZ4 had brought it down to 40% of baseline. CRP was inhibited the most among ACR50 responders, but with wide variations.

Other biomarkers also decreased significantly at week 52 among responders, but not among non-responders, suggesting a specific response profile for TCZ early ,and that the specific biomarkers may possess predictive properties for TCZ response.

Dose-dependent biomarker profiles were significantly different between ACR50 responders, non-responders, and early non-responders.

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